Zhanna Giasyan - Regulatory Affairs and Quality Assurance Specialist, Independent Entreprenuer

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Work Background

Accelsiors CROJunior Regulatory Affairs Manager

Mar. 2019Yerevan, Armenia1. Overseeing preparation, review and submission of clinical trial regulatory documents and responses to questions to central authority (Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other authorities for the assigned country/countries) and ensuring submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines. 2. Reviewing labels and ensuring that IP labels are in adherence to country requirements and submitted where applicable. 3. Acting as the main point of contact for clients (sponsor) for all aspects related to clinical study registration to Competent Authorities and Ethics Committees throughout the study lifecycle. 4. Attending internal and external project team meetings as determined by the Project Manager. 5. Providing leadership in assigned projects in terms of regulatory submissions in line with established strategies and timelines. 6. Coordinating with other departments to achieve project goals. 7. Maintaining in-depth knowledge on regulatory requirements for assigned countries and EU requirements, laws and regulations related to clinical study applications and amendments to Competent Authorities and Ethics Committees by regularly monitoring relevant resources and websites.

FMD K&LRegulatory Affairs Specialist / Project Team Lead

Mar. 2017 - Aug. 2018Yerevan1. Monitored the processing of Requests by Team and supported the team members to resolve issues. 2. Updated Regulatory Information Management System (for drugs with marketing authorization) based on Requests submitted by the Project Business User. 3. Performed activities to take information from Requests and populate in Validated Software System. 4. Processed new, copy and update Requests, made data clean up, handled mail correspondence, communicated with Business Users and supported them. 5. Performed verification of new entries or modifications in System to ensure correctness and consistency of data. 6. Supported the Admin team to coordinate the fulfillment of any special Requests. 7. Utilized all data fields available in the System Registration Records based on local and regional requirements.

ARPIMED LLCHead of Quality Assurance Department

May. 2013 - Mar. 2017c. Abovyan, 2204, Republic of Armenia1. Developed and implemented the Quality department’s strategy, to ensure it met the business requirements and customer deliverables, as well as ensured the departmental performance against goals. 2. Implemented and monitored all Quality Assurance systems to ensure compliance with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use. 3. Acted as the main point of contact on all Quality matters, internally and externally. 4. Managed all validation activities, including validation strategy and approval of protocols and reports. 5. Ensured appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved). 6. Wrote SOPs, reviewed batch records and handled deviations, complaints, CAPAs and change controls.

Natali Pharm LLC (Drugstore chain)Manager of Pharmacy

Aug. 2011 - Feb. 2013Armenia, 0065, Yerevan, Tichinai St. 3rd Lane, 2/2 Building. Yerevan, 10 T. Mets1. Ordered all pharmacy supplies and kept a check on inventory levels. 2. Inspected drug storage sites, monitored drug supply expiration dates and ensured proper supply levels. 3. Advised customers on selection and use of non-prescription medication. 4. Checked prescriptions for proper dosage. 5. Communicated regularly with physicians, nurses and insurance companies. 6. Dispensed prescribed pharmaceuticals to customers or to other health care professionals and advised them on indications, contra-indications, adverse effects, drug interactions and dosage. 7. Supervised and coordinated the activities of other pharmacists, pharmacy assistants, pharmacy technicians and other staff.

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